Experience Qualifications 7 or More Years in the pharmaceutical industry 4 or More Years in regulatory affairs, NDA, sNDA, BLA... with FDA; direct, coordinate and implement the preparation of all regulatory submissions and provide regulatory support...
Affairs Knowledge of IND, NDA/BLA submission experience Experience with regulatory submission strategy globally... and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development...
and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs... assigned to alliance assets for operational matters. Responsibilities: Develop and implement US regulatory strategy...
to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational...
within CSPV and external functions including Clinical Development, Research Development, Regulatory Affairs. Facilitate... Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service...